跳至主要内容
临床试验/NCT04090112
NCT04090112已完成不适用

Comparison of Effectiveness Between the Combination of Lidocaine Sprayed at Laryngeal Inlet and on the Cuff of Endotracheal Tube Versus Intravenous Lidocaine for Reducing Cough During Extubation: A Prospective Randomized Controlled Trial

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
1
主要终点
Change in incidence of coughing

研究概览

简要总结

Coughing during extubation of endotracheal tube (ETT) is a common problem that leads to poor surgical results including hemodynamic change, rebleeding at the surgical wound and wound dehiscence. Recently, lidocaine has been introduced for reducing coughing during extubation. However, data comparing routes of lidocaine application are lacking, thus, this study compared the combination of lidocaine sprayed on laryngeal inlet and cuff of ETT versus intravenous lidocaine injection for efficacy in reducing coughing

详细描述

A prospective randomized control trial was conduct with 164 patients. They were randomly allocated into Gr. A and B. Group A received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation. The same general anesthesia protocol was applied in all of the patients. Incidence and severity of cough during extubation was evaluated. Furthermore, incidence of 24-hour postoperative adverse events (including sore throat, dysphagia, and hoarseness) and hemodynamic response after extubation were analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The study based on a sequentially numbered list were prepared in the same way. Participant and outcome assessor were blined to the computer generated lists

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients who underwent elective surgery with American Society of Anesthesiologists physical status classifications of I and III

排除标准

  • patients having body mass index more than 35 kg/m2, high risk of aspiration, chronic smokers more than ten pack-years, chronic cough or recent upper respiratory infection, suspected difficult airway, retained ETT prior surgery, surgery at oral cavity, neck and thoracic region, operative time more than 120 minutes or less than 30 minutes, and history of lidocaine allergy

研究组 & 干预措施

the study group (Group A)

Experimental

Patients received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet

干预措施: 10% lidocaine sprayed (Drug)

Comparator group (Group B)

Active Comparator

Patients received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation

干预措施: 2% lidocaine intravenous (Drug)

结局指标

主要结局

Change in incidence of coughing

时间窗: the incidence was recorded during extubation and immediatly extubation

Coughing event was recorded by blinded anesthesiologist

次要结局

  • Severity of coughing(the severity was recorded during extubation and immediatly extubation)
  • Incidence of postoperative sore throat(the incidence was recorded within 24 hr after extubation)
  • Incidence of dysphonia(the incidence was recorded within 24 hr after extubation)
  • Incidence of dysphagia(the incidence was recorded within 24 hr after extubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pornthep Kasemsiri

Clinical Associate Professor

Khon Kaen University

研究点 (1)

Loading locations...

相似试验